The use of flexible containers filled with sterile fluids is generally known in the art. Further, the manufacture and use of sterile transfer sets which can be coupled to the flexible containers, usually via a dispensing port, are also generally known in the art.
Such fluid-filled containers and related transfer sets are routinely used for a variety of medically-related procedures. These include, dispensing of blood components, and dispensing and receiving peritoneal dialysis fluid. Further, the dispensing of various types of nutritional, parenteral and other medicinal solutions is well known.
The prior art transfer sets have often been formed of a medical grade vinyl plastic. The solution filled containers are often sterilized using steam sterilization in an autoclave. However, because of a tendency of the interior surfaces of the lumens of the transfer sets to soften and stick together, thereby blocking the fluid flow passages, such sets have not been routinely sterilized using heat. Rather, the transfer sets have very often been sterilized by means of radiation or gas.
It has also been generally known in the art to permanently couple the transfer sets to the fluid dispensing port of the container by means of a plastic softening solvent. The solvent bonds a selected connector or end of the lumen of the transfer set to the dispensing port on the container. There are circumstances where it is undesirable or not feasible to use solvent to bond these two members together. This is particularly the case where it is desirable to make sure that no solvent or solvent residue can be transfered to the fluid in the container.
Thus, there continues to be a need for a method of coupling a transfer set to a fluid-filled container which does not utilize known solvents. Further, there continues to be a need for sterile transfer sets coupled to fluid-filled containers where the sterilization of the container, the fluid and the transfer set has been carried out in a single step.